Parexel Blog

Parexel Blog

  • Insights that accelerate timelines for patients in need

    Insights that accelerate timelines for patients in need

    What if you could shorten enrollment timelines in rare disease clinical trials, not by enrolling patients in the study’s control arm, but by using data already stored in healthcare...

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  • A Complete Life Sciences Platform...It’s About Time.

    A Complete Life Sciences Platform...It’s About Time.

    Chances are, we will all be a patient at some point in our lives. As mothers, fathers, sisters, brothers and friends, we realize that time is precious, whether it be attending our children’s...

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  • Imagine if… we all focused every day on the impact we can make by bringing new treatments to patients more quickly.

    Imagine if… we all focused every day on the impact we can make by bringing new treatments to patients more quickly.

    Over the course of my career, I’ve had the privilege to work in many roles across the healthcare landscape.  Regardless of the role, I’ve always focused my...

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  • FDA Needs To Know How 503B Compounders Work

    FDA Needs To Know How 503B Compounders Work

    FDA recently published a notice in the Federal Register regarding proposals to collect information during proposed research initiatives to understand challenges and opportunities encountered...

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  • FDA & EMA Joint Report on Early Access Pathways

    FDA & EMA Joint Report on Early Access Pathways

    FDA recently published in coordination with the European Medicines Agency (EMA) a report from a joint FDA-EMA workshop with stakeholders on supporting product quality development in early access...

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  • Workforce Readiness: Cultures, Tools and Skills Needed by Organizations and Employees to Drive Innovation in Drug Development

    Workforce Readiness: Cultures, Tools and Skills Needed by Organizations and Employees to Drive Innovation in Drug Development

      This article was originally published as a whitepaper in Pharmaceutical Executive.   Despite significant investment in pharmaceutical research and development (R&D),...

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  • CBER Launches CATT to Facilitate Innovation

    CBER Launches CATT to Facilitate Innovation

    CBER Advanced Technologies Team (CATT) is a new program designed to address regulatory challenges associated with development of advanced technologies for manufacturing and testing of CBER...

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  • RIM Blog Series – Part 4: The Special Relationship Between Product and Process Data

    RIM Blog Series – Part 4: The Special Relationship Between Product and Process Data

    In my previous articles I talked about the history of RIM, structural must-haves, and provided a quick list of these features for a RIM system.   If you missed them, you can find all the...

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  • How CAR-T cell and gene therapies are redefining the traditional pharmaceutical pricing and reimbursement model

    How CAR-T cell and gene therapies are redefining the traditional pharmaceutical pricing and reimbursement model

    Very high prices plus limited immature data – the perfect payer storm Several emerging classes of transformational therapies, such as CAR-T cell and gene therapies, offer potentially curative...

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  • Heart Failure Trial Endpoints: Public Feedback on the Recent FDA Draft Guidance

    Heart Failure Trial Endpoints: Public Feedback on the Recent FDA Draft Guidance

    The FDA recently released a draft guidance titled, “Treatment for Heart Failure: Endpoints for Drug Development.”  This is a very informative document, since a main reason why FDA drafted it is to...

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  • New Zealand Consultation on Proposed Warning Statements for Allergens in Medicines

    New Zealand Consultation on Proposed Warning Statements for Allergens in Medicines

    Medsafe opened a public consultation on 27th June, they are proposing that manufacturers of medicines and related products include substances that may cause an allergic reaction on their...

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  • All EU Members Have Now Joined!

    All EU Members Have Now Joined!

    The pharmaceutical facility current Good Manufacturing Practice (cGMP) inspections are the key to ensure the quality of drugs/medicines for the patients around of the world.  While it is critical...

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  • RIM Blog Series - Part 3: Critical Features for a Successful RIM Platform

    RIM Blog Series - Part 3: Critical Features for a Successful RIM Platform

    In my previous articles (Part 1, Part 2) we talked about the history of RIM and structural must-haves for a RIM system. It’s also important to know the questions that will be asked of the data as...

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  • Former FDA expert provides valuable advice on INTERACT programs for CBER products

    Former FDA expert provides valuable advice on INTERACT programs for CBER products

    Many sponsors of CBER-regulated products are familiar with pre-IND meetings, but there’s a new program called INTERACT, which stands for Initial Targeted Engagement for Regulatory Advice on CBER...

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  • English Requirement for FDA GMP Documents

    Generally, overseas manufacturers in non-English speaking countries have their GMP documentation in the local language so that the staff working at the facility are able to read and understand the...

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  • #ParexelWithPride - Employee contributes to the landmark ruling in Botswana

    On Tuesday, June 11, the High Court of Botswana issued a unanimous decision decriminalizing same-sex sexual conduct between consenting adults.  The Southern Africa Litigation Centre (SALC) hailed...

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  • RIM Blog Series - Part 2: Mind the gap

    As discussed in my previous paper, RIM started about 15 years ago and is a discipline that supports Life Sciences Regulatory Processes. In 2003, capturing Regulatory information was a...

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  • Improving the Odds of Success in Prostate Cancer Therapy Development

    Improving the Odds of Success in Prostate Cancer Therapy Development

    In recognition of Men’s Health Month, Parexel offers a deep dive into the challenges of developing therapies for prostate cancer.  Despite significant research advances, prostate cancer remains...

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  • Thank you for Joining with Parexel to Mark International Clinical Trials Day

    Thank you for Joining with Parexel to Mark International Clinical Trials Day

    Over the last few weeks Parexel has been celebrating International Clinical Trials Day, aimed at raising awareness of the impact of clinical trials and honoring the patients participating in...

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  • Bispecific Antibody Development Program Guidance

    Earlier this month FDA released a draft guidance called “Bispecific Antibody Development Programs”.  This is a welcome addition to FDA’s set of guidance documents for biotechnology...

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